Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine whether a limited duration of treatment (two weeks of low molecular weight treatment) is a safe and effective treatment for distal deep vein thrombosis of the lower limb.

Clinical Trial Description

Approximately 50% of symptomatic episodes of deep vein thrombosis (DVT) will be confined to the calf veins (distal DVT). The proportion of distal DVT that propagate to the proximal veins, increasing the risk of pulmonary embolism, is not known. The best treatment of isolated distal DVT is therefore controversial and options include no treatment, follow-up scanning and treatment of only those patients with thrombus propagating to proximal veins, and full anticoagulation for periods ranging from 2 weeks to 3 months.

There is good evidence that the 3-month thromboembolic risk in patients with a negative CUS that is limited to the proximal veins is low, in the order of 1%. Previous studies have demonstrated that patients treated with a short period of anticoagulation (4-6 weeks) have a low risk of developing recurrent DVT or PE. In addition, the specificity of CUS for distal DVT is lower than that for proximal DVT, increasing the proportion of false positive findings, making it likely that a proportion of patients diagnosed with distal DVT are treated unnecessarily, with the attendant risks of major and fatal haemorrhage.

The need for anticoagulation of patients with distal DVT to prevent recurrent DVT is therefore uncertain, however a survey of current practice suggested that most patients with this condition currently receive antithrombotic therapy. The impact of anticoagulation on initial patient symptoms, and the subsequent risk of the post-thrombotic syndrome are also unclear, and may be a possible alternative justification for antithrombotic therapy.

In this proposed multicentre, prospective, cohort study, we plan to determine if a shorter duration of anticoagulation (minimum 2 weeks) is a safe and effective treatment for isolated distal vein thrombosis. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01252420
Study type	Interventional
Source	Monash Medical Centre
Contact
Status	Recruiting
Phase	Phase 4
Start date	November 2010
Completion date	November 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05050617` - Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
Terminated	`NCT04558125` - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism	Phase 4
Not yet recruiting	`NCT06017271` - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Completed	`NCT03915925` - Short-term Clinical Deterioration After Acute Pulmonary Embolism
Completed	`NCT02502396` - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
Recruiting	`NCT05171075` - A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE	Phase 3
Completed	`NCT04454554` - Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
Completed	`NCT03173066` - Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography	Phase 1
Terminated	`NCT03002467` - Impact Analysis of Prognostic Stratification for Pulmonary Embolism	N/A
Completed	`NCT02334007` - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery	Phase 1/Phase 2
Completed	`NCT02611115` - Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.	N/A
Completed	`NCT01975090` - The SENTRY Clinical Study	N/A
Not yet recruiting	`NCT01357941` - Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)	N/A
Completed	`NCT01326507` - Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism	N/A
Completed	`NCT00771303` - Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
Completed	`NCT00773448` - Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism	N/A
Completed	`NCT00720915` - D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months	N/A
Completed	`NCT00780767` - Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism	Phase 2
Completed	`NCT02476526` - Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease	Phase 4
Completed	`NCT00816920` - Natural History of Isolated Deep Vein Thrombosis of the Calf

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis — TWISTER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms